Senior Clinical Research Director, Ophthalmology

Role Summary

Senior Clinical Research Director (CRD) is an ophthalmology medical lead for one or several indications within an R&D program, responsible for leading clinical teams to deliver successful trials of novel ophthalmic therapeutics. This role requires clinical leadership, strong organizational skills, strategic and operational focus, and the ability to coordinate with internal and external stakeholders. Location: Morristown, NJ or Cambridge, MA.

Responsibilities

• Provide ophthalmology focused medical and scientific expertise to the cross functional project team to conduct the clinical studies from early phases to lifecycle management (LCM) programs
• Establish clinical development strategy and lead clinical team, collaborating with other medical and clinical scientific experts, clinical development scientists in the project in collaboration with the Safety Officer, Regulatory Strategist, Statistics and other key functional representatives to deliver development strategy and prepare/assist with regulatory agency interactions
• Develop or contribute to the regulatory documentation for the project(s), provide clinical leadership to other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment)
• Provide appropriate medical input and clinical leadership for all activities related to study conduct such as responses to IRBs and Health Authorities questions, protocol scientific and medical training, medical review of data within the scope of centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
• Responsible for the clinical part of regulatory documents, Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA) and answers to questions from health authorities
• Serve as the medical expert in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other clinical team members, with capacity to train them on the medical/scientific strategy by indication

Skills

• Has and maintains deep scientific, technical, and clinical expertise in ophthalmology and retinal diseases
• Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest
• Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
• Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders

Education

• MD with ophthalmology residency training; fellowship training highly preferred

Qualifications

• Required: Medical Doctor (MD) and ophthalmology residency training
• Required: Minimum 5 years of clinical trial and/or clinical development experience
• Required: Fluent in English (verbal and written)
• Preferred: Fellowship training
• Preferred: Board certified or eligible in Ophthalmology
• Preferred: Strong scientific and academic background with deep understanding of retina and eye diseases
• Preferred: Clinical trial or pharmaceutical experience in ophthalmology
• Preferred: Knowledge of drug development, ocular gene therapy, regulatory strategy
• Preferred: Good networking ability in cross-cultural environment
• Preferred: Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
• Preferred: Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
• Preferred: Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills